[Federal Register Volume 64, Number 180 (Friday, September 17, 1999)]
[Rules and Regulations]
[Pages 50445-50448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98P-0968]


Food Labeling: Declaration of Ingredients

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
ingredient labeling regulations to permit the use of ``and/or'' 
labeling for the various fish species used in the production of certain 
processed seafood products, i.e., surimi and surimi-containing foods. 
This action responds to a petition submitted by the National Fisheries 
Institute (NFI) requesting more flexible ingredient labeling for the 
fish ingredients used in the production of surimi products. This rule 
will permit manufacturers of surimi and surimi-containing products to 
maintain a single label inventory identifying all of the fish species 
that are used in the manufacture of these products.

DATES: This rule is effective on September 17, 1999.

FOR FURTHER INFORMATION CONTACT: Linda J. McCollum, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

 I. Background

     In the Federal Register of April 9, 1999 (64 FR 17295), FDA 
published a proposal to amend the ingredient labeling regulations 
(hereinafter referred to as the April 9 proposal) to permit the use of 
``and/or'' labeling for the various fish species used in the production 
of certain processed seafood products such as surimi and surimi-
containing foods. The April 9 proposal responded to a citizen's 
petition submitted by NFI, which requested that FDA allow more flexible 
ingredient labeling for the fish ingredients used as a component in 
surimi production. NFI asserted that the use of ``and/or'' labeling 
would have two advantages: (1) Reduce the economic burden on 
manufacturers of having to maintain extensive label inventories to 
account for all possible fish species or predominance combinations used 
and (2) enable manufacturers to effectively manage harvestable 
resources by allowing them to take advantage of the varying species and 
quantities of fish available at different times of the year. The 
petitioner also asserted that because the fish ingredients are 
thoroughly decharacterized during processing, the specific fish species 
used does not influence the nutritional content or product character, 
nor does it influence consumer-purchasing decisions.
     In regard to the fish ingredients used to produce surimi, the NFI 
petition described them as refined myofibrillar protein products. The 
processing of the fish ingredients is such that the fish, regardless of 
species, are headed, gutted, filleted, skinned, deboned, and minced. 
The minced flesh is then washed and screened to decharacterize the 
tissue by removing blood, fat, pigments, and enzymes characteristic of 
the fish species, resulting in a slurry not recognizable as fish flesh. 
The fish ingredient used as a component of surimi is a washed, 
dehydrated slurry devoid of color, odor, texture, and taste. Surimi, an 
intermediate processed seafood product, is made by mixing 
cryoprotectants into the myofibrillar protein base then extruding it. 
It can be used fresh or stored frozen until processed further into 
seafood analog food products (Ref. 1).
     Based on FDA's review of the information provided in the petition, 
and other information available to the agency describing the production 
of surimi, we tentatively found in the April 9 proposal that the use of 
``and/or'' ingredient labeling for the declaration of the fish species 
in certain processed seafood products is consistent with other 
exceptions to the ingredient labeling requirements providing for ``and/
or'' labeling. The agency also tentatively found that such labeling 
would not compromise the type or amount of information received by the 
consumer regarding surimi and surimi-containing foods. Consequently, in 
the April 9 proposal, FDA proposed to amend its ingredient labeling 
regulations to permit the use of ``and/or'' labeling for the fish 
ingredient present in surimi and surimi-containing foods. Specifically, 
the agency proposed that when processed seafood products contain fish 
protein ingredients consisting primarily of the myofibrillar protein 
fractions from one or more fish species and the manufacturer is unable

[[Page 50446]]

to adhere to a constant pattern of fish species in the fish protein 
ingredient, because of seasonal or other limitations of species 
availability, the common or usual name of each individual fish species 
need not be listed in descending order of predominance. Fish species 
not present in the fish protein ingredient may be listed if they are 
sometimes used in the product. Such ingredients must be identified by 
words indicating that they may not be present, such as ``or,'' ``and/
or,'' or ``contains one or more of the following:'' e.g., ``fish 
protein (contains one or more of the following: Pollock, cod, and/or 
pacific whiting).'' Interested persons were given until June 23, 1999, 
to comment on the April 9 proposal.

 II. Comments and Agency Response

     In response to the April 9 proposal, FDA received 16 letters, each 
containing 1 or more comments. The comments were from government, 
industry, industry trade associations, academia, and consumer 
organizations. All of the comments agreed with the agency's decision to 
amend the ingredient labeling regulations in 21 CFR 101.4(b) 
(Sec. 101.4(b)) to permit the use of ``and/or'' labeling for the 
various fish species used in the production of surimi and surimi-
containing foods.
     1. Several comments requested that FDA immediately issue a letter 
advising manufacturers that the agency would use its enforcement 
discretion and permit ``and/or'' labeling consistent with the proposed 
rule until a final rule is published. The comments asserted that such 
action would provide relief from onerous labeling requirements. The 
agency did not act on the request for enforcement discretion because of 
the short timeframe in which it intended to publish the final rule. The 
agency considered it a more efficient use of its resources to 
concentrate on completing the final rule in accordance with Congress' 
intent that the agency publish the final rule within 1 year of 
receiving the petition. FDA, in publishing this final rule within that 
timeframe, has met congressional intent. Further, this final rule is 
effective on the date of publication in the Federal Register; 
therefore, the comment is moot.
     2. A few comments suggested revising the ingredient statement so 
that all possible species of fish that can be used for the fish 
ingredient of surimi and surimi-containing foods would be included in 
the ingredient statement. They proposed that this be done by either 
leaving a blank for other species names or adding ``may'' to the 
``contains... and/or'' statement.
     The agency does not agree with this suggestion. The agency 
believes there is an intrinsic difference between the phrase ``may 
contain,'' with the inherent suggestion that the food may or may not 
contain the named species, and the phrase ``contains * * * and/or.'' 
FDA believes that the statement that a food may contain a particular 
fish species would be useless to consumers because the statement would 
not advise them whether the product would ever contain the fish species 
named. On the other hand, ``and/or'' labeling informs the consumer that 
one or more of the fish species declared is sometimes present in the 
product. Therefore, the agency is not granting the request to allow the 
use of the term ``may contain'' in the declaration of fish species in 
fish protein. The language of the final rule provides for the inclusion 
of any species of fish that is sometimes used in the surimi or surimi-
containing product and is consistent with all other regulations in 
Sec. 101.4(b) where the use of ``and/or'' labeling is allowed.
     3. Some comments disagreed with the use of the term ``fish 
protein'' as an appropriate common or usual name in the ingredient 
list. Several comments questioned whether FDA used the term ``fish 
protein'' as an example and did not intend to preclude the use of other 
terms. They requested that FDA clarify that the term ``fish protein'' 
was just an example of an acceptable term for the fish ingredient. The 
comments asserted that other terms such as ``fish'' or ``fish blend'' 
rather than ``fish protein'' would be better for both industry and 
consumers as the descriptive name, noting that other countries use 
these names for labeling this ingredient.
     Another comment stated that ``fish protein'' would be an 
inappropriate and confusing term for consumers. The comment contended 
that consumers would equate ``fish protein'' with denatured fish 
protein concentrate that is used in fish fertilizer or in animal feed.
     The term ``fish protein,'' as used in the context of this 
regulation, is a collective (generic) name to describe the fish 
ingredient. FDA believes that the use of ``fish'' or ``fish blend'' is 
not an appropriately descriptive collective name, as it does not 
sufficiently describe the basic nature of the food ingredient. 
According to the petition, the ingredient used in surimi is processed 
fish muscle tissue that has been totally decharacterized by being 
defatted, decolorized, deflavorized, deodorized, and mechanically 
detexturized. Consequently, the basic nature of the food is no longer 
``fish'' as is commonly understood by consumers. The term ``fish'' or 
``fish blend'' implies the use of the natural fish flesh in the 
product; whereas, the organoleptic properties and nutritional values of 
the fish in surimi products are significantly modified. Further, the 
agency accepted industry's position that ``and/or'' labeling was 
appropriate for the fish protein ingredient because the species from 
which the fish protein is derived are no longer distinguishable (64 FR 
17295 at 17297).
     In response to the comment regarding consumer perception, FDA is 
not persuaded that consumers will confuse ``fish protein'' with 
ingredients used in fertilizer or animal feed. The comment did not 
provide data or other evidence supporting the contention that consumer 
confusion would occur. Further, even though other human food 
ingredients, such as liver or chicken, are declared on pet food labels 
FDA is unaware of complaints or inquiries based on confusion of the 
suitability of the ingredients.
     Therefore, having considered the suggestions in these comments, 
the agency concludes that the most appropriate collective term is 
``fish protein.'' In the absence of an appropriate alternative 
collective term the agency disagrees with the comments that requested 
the agency to clarify that ``fish protein'' was intended to be only an 
example of an acceptable ingredient name. At this time, ``fish 
protein'' is the collective name that should be used to designate the 
fish ingredient in surimi. The agency has modified the language in the 
final rule to clarify this point. We recognize, however, that there 
might be other terms that could appropriately describe the fish 
ingredient. Thus, we are willing to consider the appropriateness of 
other terms on a case-by-case basis as submitted in a citizen's 
petition.
     4. One comment that supported use of the term ``fish'' as an 
appropriate descriptive name also suggested that the ingredient 
statement of surimi include percentage designations as follows: ``Fish 
(may contain one or more of the following: Pollock * * *) 50%, water 
30% and other ingredients 20%.''
     FDA believes that an ingredient statement is sufficiently 
informative when it lists the ingredients in order of predominance by 
weight. However, voluntary percentage declaration of ingredients is 
provided for in Sec. 101.4(e). Furthermore, based on the arguments 
presented in the petition, the agency questions the practicability of 
percent ingredient labeling for these products because of its potential 
to negate the usefulness of the ``and/or'' labeling format by requiring 
a different label for

[[Page 50447]]

each different recipe of the surimi product. Therefore, the agency 
concludes that it is neither necessary nor appropriate to amend the 
regulations as suggested by the comment.
     5. One comment requested that FDA broaden the scope of the 
proposal to allow for the use of ``and/or'' ingredient labeling for 
other fish ingredient products that may not meet the technical 
description of surimi. This comment requested that minced fish 
ingredients used in products such as fish sticks and portions that 
conform to 21 CFR 102.45 (Sec. 102.45) and fish ingredients for stews, 
soups, and chowders also be included in this rule. The comment 
contended that these products rely on substantially the same fish 
species used in surimi and, therefore, are subject to the same 
seasonality, quota limitations, and labeling costs as surimi. Further, 
the comment argued that processing of these types of ingredients 
decharacterizes the fish species ``to an extent'' and the final product 
may be made from a blend of several fish species.
     FDA is not persuaded by the comment that it should broaden the 
scope of this regulation to provide for ``and/or'' labeling to other 
forms of fish ingredients such as minced fish. Surimi is a unique 
product unrecognizable as fish due to its extensive processing. Because 
the washed, blended minced fish and similar types of ingredients used 
in making fish sticks and the other products mentioned in the comment 
still retain taste and texture characteristic of the fish species used, 
we believe it is inappropriate to include them under this regulation. 
Fish sticks and portions made from minced fish are appropriately 
labeled under Sec. 102.45.

 III. Analysis of Economic Impacts

 A. Benefit-Cost Analysis

     FDA has examined the impacts of this rule under Executive Order 
12866. Executive Order 12866 directs Federal agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages, distributive impacts, and 
equity). According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. FDA 
finds that this rule is not a significant regulatory action as defined 
by Executive Order 12866. In addition, it has been determined that this 
rule is not a major rule for the purpose of congressional review. For 
the purpose of congressional review, a major rule is one which is 
likely to cause an annual effect on the economy of $100 million; a 
major increase in costs or prices; significant effects on competition, 
employment, productivity, or innovation; or significant effects on the 
ability of U.S.-based enterprises to compete with foreign-based 
enterprises in domestic or export markets.
     FDA agrees with the petitioner that the current combination of 
seasonal species harvests, harvesting limits, labeling regulations, and 
limited product storage times places an unwarranted and costly 
logistical burden on surimi manufacturers. This combination of 
circumstances forces surimi manufacturers to maintain and coordinate 
several inventories of species-specific surimi and contingent labels 
that declare the specific fish species used to make the surimi. The 
convergence of these conditions also hampers the seafood industry's 
efforts to use conventional and innovative surimi processing 
technologies to optimize fishery yield.
     This rule will mitigate the logistical burden faced by surimi 
manufacturers. Because surimi manufacturers will be able to maintain a 
single label inventory and use innovative technologies, they will be 
able to operate more efficiently. Because of lower production costs, 
consumers may see slightly lower prices for surimi. Because of the 
greater flexibility for species usage, the goals of fisheries 
management will be easier to achieve.
     This rule will not result in any increase in societal costs. 
Because the rule is permissive, there are no costs imposed on 
producers. Because the new labels adequately inform consumers there 
will be no costs to them in terms of lost information or increased 
search costs. FDA received no comments to the April 9 proposal 
concerning its analysis of economic impacts.

 B. Small Entity Analysis

     FDA has examined the impacts of this rule under the Regulatory 
Flexibility Act (RFA). The RFA (5 U.S.C. 601-612) requires Federal 
agencies to consider alternatives that would minimize the economic 
impact of their regulations on small businesses and other small 
entities. In compliance with the RFA, FDA finds that this rule will not 
have a significant impact on a substantial number of small entities.
     No costs will be generated by this final rule because it will not 
require any labels to be changed, or any product to be reformulated. 
Therefore, small businesses will only relabel or reformulate products 
if the benefits of ``and/or'' labeling outweigh the costs. Accordingly, 
under the RFA (5 U.S.C. 601-612), the agency certifies that this rule 
will not have a significant economic impact on a substantial number of 
small entities.

 C. Unfunded Mandates Reform Act of 1995

     FDA has examined the impacts of this rule under the Unfunded 
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This rule does 
not trigger the requirement for a written statement under section 
202(a) of the UMRA because it does not impose a mandate that results in 
an expenditure of $100 million (adjusted annually for inflation) or 
more by State, local, and tribal governments in the aggregate, or by 
the private sector, in any one year.

 IV. Environmental Impact

     The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (68 FR 17295 at 17298). No 
new information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that neither an environmental assessment nor 
an environmental impact statement is required.

 V. Paperwork Reduction Act of 1995

     This rule contains ingredient declaration provisions that fall 
within the scope of the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). In the April 9 proposal the agency tentatively concluded 
that the proposed provisions for the declaration of fish ingredients 
using ``and/or'' labeling would not impose any new information 
collection requirements. We did not receive any comments on this issue. 
Therefore, the agency concludes that the provisions set forth below for 
the declaration of fish ingredients using ``and/or'' labeling do not 
impose any new information collection requirements because they create 
an exception from existing ingredient declaration requirements to make 
compliance easier. The ingredient declaration burden under 
Sec. 101.4(b) has been approved by the Office of Management and Budget 
(OMB control number 0910-0381).

[[Page 50448]]

 VI. References

     The following reference has been placed on display at the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
     1. Lee, C. M., ``Surimi Process Technology,'' Food Technology, 
pp. 69 to 80, 1984.

 List of Subjects in 21 CFR Part 101

     Food labeling, Nutrition, Reporting and recordkeeping 
requirements.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 101 is amended as follows:

 PART 101--FOOD LABELING

     1. The authority citation for 21 CFR part 101 continues to read as 
follows:
    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.
     2. Section 101.4 is amended by adding paragraph (b)(23) to read as 
follows:


Sec. 101.4   Food; designation of ingredients.

* * * * *
     (b) * * *
     (23) When processed seafood products contain fish protein 
ingredients consisting primarily of the myofibrillar protein fraction 
from one or more fish species and the manufacturer is unable to adhere 
to a constant pattern of fish species in the fish protein ingredient, 
because of seasonal or other limitations of species availability, the 
common or usual name of each individual fish species need not be listed 
in descending order of predominance. Fish species not present in the 
fish protein ingredient may be listed if they are sometimes used in the 
product. Such ingredients must be identified by words indicating that 
they may not be present, such as ``or'', ``and/or'', or ``contains one 
or more of the following:'' Fish protein ingredients may be declared in 
the ingredient statement by stating the specific common or usual name 
of each fish species that may be present in parentheses following the 
collective name ``fish protein'', e.g., ``fish protein (contains one or 
more of the following: Pollock, cod, and/or pacific whiting)''.
* * * * *

    Dated: September 13, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-24235 Filed 9-16-99; 8:45 am]
BILLING CODE 4160-01-F